Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Taxane

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

bevacizumab and chemotherapy given every 21 day untill disease progression or unacceptable toxicity

-bevacizumab 15m.g/ kg + carboplatin 450m.g + paclitaxel 175m.g/m2 D1 /21 Day until disease progression or un acceptable toxicity .

assuit university

Evaluating efficacy and safety of bevacizumab when combined with chemotherapy (carboplatin and Paclitaxel ) in treatment of patient with metastatic triple negative breast cancer

Breast cancer is the most common non cutaneous cancer in U.S. women, with an estimated 63,960 cases of in situ disease and 266,120 cases of invasive disease in 2018. (American Cancer Society: Cancer Facts and Figures 2018). On the basis of ER, PR, and HER2/neu results, breast cancer is classified as one of the following types:

Hormone receptor positive , HER2/neu positive and Triple negative (ER, PR, and HER2/neu negative).

ER, PR, and HER2 status are important in determining prognosis and in predicting response to endocrine and HER2-directed therapy.(Harris JR, Morrow M, Lippman ME, et al . 1996) Metatstaic Triple-negative breast cancer (TNBC) is a diagnosis of exclusion, defined by the lack of expression of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) .

TNBC tends to occur in younger, often premenopausal patients, African Americans, and in association with hereditary syndromes, most commonly germline BRCA1 mutations. It constitutes up to 15% of all breast cancers but accounts for \> 25% of breast cancer-related deaths as it has an inherent predisposition for rapid dissemination and visceral metastases with limited improvements in overall survival and inferior clinical outcomes . It is characterized by higher incidence of brain metastases and rapid progression from the onset of metastasis to death. Having aggressive biology more than other breast types due to high risk of early relapse between the first and third years after diagnosis , metastases are rarely preceded by local recurrence and most deaths occur in the first 5 years ( Livasy CA et al . 2006 ) Due to the palliative intent of treatment as in MBC and Optimal chemotherapy regimens have yet to be established in treatment of metastatic TNBC; however, there have been advances in the systemic treatment of triple-negative breast cancer in the neoadjuvant, adjuvant, and metastatic settings. ( J.M. Lebert , R. Lester , E. Powell et el current oncology journal 2018 ) it is critical that an individualized approach is taken that incorporates patient, disease, and treatment-related factors, including an individual oncologist treatment preference.(Geels P, et al 2000 ).

There have been several head-to-head chemotherapy trials performed within the metastatic setting, and much of what is applied in clinical practice is extrapolated from chemotherapy trials in the adjuvant setting, with taxanes and anthracyclines incorporated early on in the patient's treatment course.

Angiogenesis is essential for the development of malignancies and plays a central role in the early stages of growth, invasion, and metastatic spread of breast cancer (BC), thus representing a reasonable therapeutic target. This evidence is a solid biological rationale for the use of therapeutic agents able to interfere with the VEGF (vaso endothelial growth factor ) function.

Breast cancer is the most common non cutaneous cancer in U.S. women, with an estimated 63,960 cases of in situ disease and 266,120 cases of invasive disease in 2018. (American Cancer Society: Cancer Facts and Figures 2018). On the basis of ER, PR, and HER2/neu results, breast cancer is classified as one of the following types:

Hormone receptor positive , HER2/neu positive and Triple negative (ER, PR, and HER2/neu negative).

ER, PR, and HER2 status are important in determining prognosis and in predicting response to endocrine and HER2-directed therapy.(Harris JR, Morrow M, Lippman ME, et al . 1996) Metatstaic Triple-negative breast cancer (TNBC) is a diagnosis of exclusion, defined by the lack of expression of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) .

TNBC tends to occur in younger, often premenopausal patients, African Americans, and in association with hereditary syndromes, most commonly germline BRCA1 mutations. It constitutes up to 15% of all breast cancers but accounts for \> 25% of breast cancer-related deaths as it has an inherent predisposition for rapid dissemination and visceral metastases with limited improvements in overall survival and inferior clinical outcomes . It is characterized by higher incidence of brain metastases and rapid progression from the onset of metastasis to death. Having aggressive biology more than other breast types due to high risk of early relapse between the first and third years after diagnosis , metastases are rarely preceded by local recurrence and most deaths occur in the first 5 years ( Livasy CA et al . 2006 ) Due to the palliative intent of treatment as in MBC and Optimal chemotherapy regimens have yet to be established in treatment of metastatic TNBC; however, there have been advances in the systemic treatment of triple-negative breast cancer in the neoadjuvant, adjuvant, and metastatic settings. ( J.M. Lebert , R. Lester , E. Powell et el current oncology journal 2018 ) it is critical that an individualized approach is taken that incorporates patient, disease, and treatment-related factors, including an individual oncologist treatment preference.(Geels P, et al 2000 ).

There have been several head-to-head chemotherapy trials performed within the metastatic setting, and much of what is applied in clinical practice is extrapolated from chemotherapy trials in the adjuvant setting, with taxanes and anthracyclines incorporated early on in the patient's treatment course.

Angiogenesis is essential for the development of malignancies and plays a central role in the early stages of growth, invasion, and metastatic spread of breast cancer (BC), thus representing a reasonable therapeutic target. This evidence is a solid biological rationale for the use of therapeutic agents able to interfere with the VEGF (vaso endothelial growth factor ) function.

The recombinant monoclonal antibody bevacizumab is currently the most widely used and developed antiangiogenic drug in the treatment of breast cancer(BC) , able to recognize all the isoforms of VEGFA, preventing its binding to the cellular receptor, and inhibiting the angiogenic and proliferative signal. In vivo studies showed that bevacizumab inhibits both proliferation and migration of endothelial cells induced by VEGFA; besides in some models of human BC, the treatment with bevacizumab was associated to a reduction in microvascular density ( Zhang W et al. 2002. ) . The humanized, anti-VEGF monoclonal antibody bevacizumab has been shown to increase progression-free survival (PFS) and/ or overall survival (OS) in metastatic breast cancer (MBC), response rate RR . ( Brufsky A, et al 2012) ( Vrdoljak E1, et al 2016 ).

In the Phase 3 RIBBON-2 study, previously treated patients with metastatic breast cancer were randomized to Avastin with chemotherapy (n=112 had triple-negative breast cancer) or chemotherapy with placebo (n=47 had triple-negative breast cancer). In an exploratory subgroup analysis of the patients with triple-negative breast cancer, median progression-free survival was 6 months vs 2.7 months (hazard ratio=0.49; p=0.0006), median overall survival was 17.8 months vs 13.5 months (hazard ratio=0.85; 95% CI, 0.58-1.26), and objective response rate was 41% vs 18% (p=0.0078). (Brufsky AM, Hurvitz S, Perez E, et al. 2012 ) In the RIBBON-1 study, chemotherapy with or without Avastin was evaluated in 1,237 patients as first-line treatment for metastatic breast cancer, 21.3% of whom had triplenegative breast cancer. In prespecified subgroup analyses, triple-negative patients demonstrated a hazard ratio for progression-free survival of 0.72 (95% CI, 0.49-1.06) and had a median progression-free survival of 6.1 vs. 4.2 months in the Avastin with capecitabine arm vs the capecitabine alone arm. In the Avastin with taxane/anthracycline cohort vs taxane/anthracycline alone cohort, triple-negative patients had a hazard ratio for progressionfree survival of 0.78 (95% CI, 0.53-1.15) with a median progression-free survival of 6.5 vs 6.2 months, respectively. (Robert NJ, Diéras V, Glaspy J, et al. RIBBON-1 ,2011) A subgroup analysis of the TURANDOT study compared first-line Avastin and paclitaxel (Arm A) with Avastin and capecitabine (Arm B) in human epidermal growth factor receptor 2-negative patients with triple-negative metastatic breast cancer (n=124). In the triplenegative breast cancer subgroup, the median overall survival was 24.4 months in Arm A and 17.7 months in Arm B (unstratified hazard ratio=1.35; 95% CI, 0.9-2.02). (Zielinski C, Lang I, Inbar M, et al. 2016) Taxanes as part of chemotherapy have been studied as having an inhibitory action on the proliferation of endothelial progenitor cells, with an antiangiogenic effect at lower doses than those needed to inhibit the proliferation of cancer cells. The resulting hypoxia induces cancer cells to a kind of "reaction" through the autocrine production of proangiogenic agents , several evidences of their benefits on clinical outcomes, such as OS, time to progression (TTP), and over all response rate ( ORR.) ( Tran J. et al. 2002.) ( Ghersi D, et al. 2015 ) . Even if conventional taxanes demonstrated to be more active in endocrine receptor-negative tumors and are indicated in the first-line treatment of TNBC . ( Isakoff SJ Cancer J. 2010 ) Because of the sensitivity of TNBC to platinum compounds and the synergistic effect of bevacizumab with paclitaxel we investigated the efficacy and toxicity of weekly paclitaxel and carboplatin in combination with bevacizumab as first-line treatment in metastatic TNBC.

phase II study followed the Simon's 2-stage optimal design. Paclitaxel (90 mg/m2) and carboplatin (2 area under the curve) were administered on days 1, 8, and 15 every 4 weeks, preceded by bevacizumab 10 mg/kg on days 1 and 15. The primary end point was the objective response rate (ORR). A total of 46 patients were enrolled. Seven (15.2%) complete and 23 (50%) partial responses were observed for an ORR of 65.2% (95% confidence interval, 52.9%-80.4%). The median progression-free survival was 10.3 months, the median overall survival 25.7 months, and the median duration of response 18.2 months. Neutropenia Grade III and IV was experienced by 13 (28.3%) and 6 (13.04%) patients, respectively. One patient developed an uneventful Grade IV thrombocytopenia. There was 1 toxic death due to febrile neutropenia. Other Grade III toxicities included anemia (n = 2), neurotoxicity (n = 2), thrombocytopenia (n = 1), and diarrhea (n = 1). No serious bevacizumab-related toxicities were observed.( Saloustros E, Nikolaou M, Kalbakis etal 2017)

Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer

Phase 2 Study to Evaluate the Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer

the length of time during and after the treatment that a patient lives with the disease but it does not get worse

length of time from the date of diagnosis to the time of death or lost follow up.

the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Assiut University

assisstant lecturer

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Anti-Infective Agents

Cytarabine

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

The test is divided into 2 stages： fist stage is dose escalation：Sintilimab 200mg，MB07133 injection is divided into three dosage groups: 600mg/m2/day, 1200mg/m2/day, and 1800mg/m2/day.

second stage Dose expansion：Sintilimab 200mg+MB07133 1800mg/m2/day

1. Adopting the classic "3+3" scheme design, 3 dose groups, with a cycle of 21 days. On the first day of each cycle, a single infusion of Sintilimab is given, and MB07133 is given for 7 consecutive days after a 2-hour interval between infusion initiation.
2. Sintilimab 200mg+MB07133 1800mg, recruiting 30 subjects，the administration method is as 1.

Sintilimab 200mg+MB07133 600mg

Ding Yanhua

Ding Yanhua, master

An open-label, multi-dose clinical trial design was used to investigate the combination of MB07133 injection combined with Sintilimab in the treatment of primary liver cancer in phase I/IIa studies, including two phases of dose escalation and dose expansion，in order to evaluate the safety and efficacy of MB07133 injection combined with Sintilimab.

MB07133 600mg/m2/day+Sintilimab 200mg、 MB07133 1200mg/m2/day+Sintilimab 200mg、 MB07133 1800mg/m2/day+Sintilimab 200mg

Treatment of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma

Safety, Tolerability and Efficacy of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma，a Phase 1/2a Study

According to the internationally recognized NCI-CTCAE 5.0 toxicity evaluation standard

All adverse medical events that occur after subjects receive the investigational product can be manifested as symptoms, signs, diseases, or laboratory abnormalities, but do not necessarily have a causal relationship with the investigational product.

The time between the start of medication and the occurrence of objective tumor progression or death（RECIST1.1 ）

The First Hospital of Jilin University

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Adenoma

Motorized Spiral Colonoscopy (MSC) with the novel motorized spiral endoscope represents a new technology which offers all of the advantageous options of spiral-assisted endoscopy with a faster and less invasive approach

For any pathological finding during colonoscopy standard endoscopic techniques, e.g. forceps biopsy, injection, endoscopic mucosal resection, argon plasma coagulation

Motorized Spiral Colonoscopy

Horst Neuhaus, MD, PhD

The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy.

Colonoscopy has been widely accepted for the diagnosis and treatment of colon diseases. Properly performed, colonoscopy is generally safe, accurate, and well-tolerated. Diagnostic colonoscopy is the preferred method to evaluate the colon in most patients with large-bowel symptoms, iron deficiency anemia, abnormal results on radiographic studies of the colon, positive results on colorectal cancer (CRC) screening tests, post-polypectomy and post-cancer resection surveillance, and diagnosis and surveillance in inflammatory bowel disease. In addition, colonoscopy has been introduced for CRC screening in some Western countries e.g. in the United States and Germany. Recent trials showed that screening colonoscopy has a large potential for prevention and early detection of colorectal cancer. Diagnostic colonoscopy is usually combined with endoscopic resection of small and medium sized polyps and flat neoplastic lesions. Patients in whom larger lesions are detected at a diagnostic colonoscopy are usually rescheduled for therapeutic colonoscopy in an appropriate setting.

Quality parameters for colonoscopy were recently reported. In terms of intraprocedural indicators a cecal intubation rate of ≥ 90% for all cases of colonoscopy is widely accepted. Even experienced endoscopists classify up to 10% of colonoscopies as difficult and intubation of the cecum may then be impossible. A recent study evaluated the efficacy and safety of repeating colonoscopy in 520 patients with prior incomplete colonoscopy. Reasons for failure to complete colonoscopy in referring institutions were "looping/redundant colon" in 53.8% of the cases, "sigmoid fixation/angulation" in 38.8%, "both sigmoid angulation and looping colon" in 5.8% of the cases. Issues with sedation caused failures in 1.5% of the patients. Conventional colonoscopy can be difficult in particular in these anatomical variations because pushing the endoscope tends to form loops with limited or no advancement of the tip of the instrument. Techniques like alternating pushing and pulling the endoscope or external compression of the abdomen are used to overcome these limitations. Loop formation and stretching the colon with the adjacent mesenterium as well as external compression are inconvenient or even painful for the patient. In addition these maneuvers prolong the procedural duration. We recently compared the use of ultrathin colonoscopies with standard colonoscope in a randomized trial in terms of cecal intubation rate, level of sedation, amount of propofol needed for sedation, number of external compressions, pain score patient satisfaction and other parameters. The results indicate that these parameters can be well used for evaluation of a new technique of colonoscopy.

Spiral assisted endoscopy is based on a completely different concept of advancing an endoscope by pleating of bowel on the instrumentation shaft by rotation. This technique has been widely used for antegrade enteroscopy. For this purpose a manually rotatable overtube is used through which a thin flexible enteroscope is inserted. The distal end of the overtube contains a raised spiral thread for pleating the small intestine over the overtube. By manually rotating the spiral element the bowel pleats onto the overtube, allowing the operator to access and visualize the more distal portions of the small intestine. Spiral assisted endoscopy has been also approved and evaluated for retrograde enteroscopy via the anal route. It promises advantage for intubation of the cecum and the terminal ileum by its principle of pleating at least parts of the colon with consecutive shortening and less loop formation. These effects should reduce the need for external compression and they may cause less pain for patients. In addition, the spiral should stabilize the position of the colonoscope which is advantageous for careful examination and targeted interventions. Spiral overtube-assisted colonoscopy achieved a success rate of cecal intubation in 92% of 24 patients in whom conventional colonoscopy had failed. However conventional spiral endoscopy is cumbersome to use and requires assistance by a second endoscopist for its appropriate use.

The Novel Motorized Spiral Endoscope represents a new technology which offers all of the advantageous options of spiral-assisted endoscopy with a faster and less invasive approach. The system is similar to other currently marketed endoscopes in that it incorporates a flexible insertion tube, light source, digital imaging, and channels for passing accessories for sample collection or therapeutic interventions. The system is unique in that it incorporates a user-controlled motor contained in the endoscope's handle to rotate a spiral cuff located on the endoscope's insertion tube. Rotation of this cuff, which has soft spiral-shaped "fins", pleats the colon on to the endoscope's insertion tube, thereby allowing rapid and atraumatic access into the colon. The system also includes a display monitor, a motor control unit, device to display measured motor current and signal torque, and a set of foot pedals. It is currently being evaluated in a prospective study in patients with indications for antegrade enteroscopy ("European Novel Motorized Spiral Endoscopy Trial (ENMSET)) in the two centers conducting this study. So far more than 60 patients were successfully examined without major adverse events.

The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation rate of at least 90 % according to quality guidelines recommendations. All other clinically relevant quality parameters of standard colonoscopy will be evaluated as secondary aims comparable to our recent trial. This study represents the first clinical evaluation of using a motorized spiral assisted endoscope for examination of the colon with potential advantages for patients in terms of effectiveness and convenience of colonoscopy.

Motorized Spiral Colonoscopy Trial: A First Feasibility Trial

Motorized Spiral Colonoscopy Trial (MSCT): A First Feasibility Trial

external compression necessary during intervention, yes/no?

sedation depth assessed by ESGE-guideline, level 1-3

Olympus

Evangelisches Krankenhaus Düsseldorf

1\~6 subjects in this cohort will receive IPG7236 50 mg bid orally.

3\~6 subjects in this cohort will receive IPG7236 100 mg bid orally.

3\~6 subjects in this cohort will receive IPG7236 150 mg bid orally.

3\~6 subjects in this cohort will receive IPG7236 200 mg bid orally.

3\~6 subjects in this cohort will receive IPG7236 250 mg bid orally.

3\~6 subjects in this cohort will receive IPG7236 300 mg bid orally.

The IPG7236 drug product is supplied as oral tablet dosage form, containing two strengths: 25 mg and 100 mg, respectively, which contain IPG7236.

IPG7236

Zhang Qi

Andrae Vandross, MD

This is a Phase 1, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients with Advanced Solid Tumors.

The study will include a dose escalation phase (Part 1) and a dose expansion phase (Part 2). Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12 hours) in continuous 28-day cycles.

IPG7236 in Patients With Advanced Solid Tumors

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors

MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 33days of multiple dosing.

The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of IPG7236

Disease Control Rate(DCR) will be determined based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Pharmacokinetic (PK) parameters after a single oral dose of IPG7236

the proportion of patients with complete response (CR) and partial response (PR)

the time from the date when the measurement criteria were met for complete or partial response (whichever occurred first) until the date of the first observed Progression Disease or death as a result of any cause.

the time the patient is enrolled to the date of any recorded disease progression or the death of any cause.

the time from clinical remission to disease progression.

Nanjing Immunophage Biotech Co., Ltd

Rare Diseases

Sarcoma

Osteosarcoma

Sarcoma, Ewing

Chondrosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

3+3 design for phase I for RP2D (Recommended Phase 2 Dose) for adolescents (12-17 years old) (15mg QD or 20mg QD); phase II for efficacy exploration for another 17 patients using RP2D QD

TQB3525 is an orally bioavailable, potent, class I kinase inhibitors of PI3Ka and PI3Kd.

TQB3525

Wei Guo, Ph.D and M.D.

The PI3K, protein kinase B (AKT), and mTOR signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control the tumor microenvironment and angiogenesis. The PI3K-AKT-mTOR axis is the most frequently deregulated signaling pathway in primary osteosarcoma and other bone tumors. PI3Ka has high rates of 25-50% activating mutations associated with tumor formation in osteosarcoma. Other causes of pathway hyperactivation include loss of function of the tumor suppressor PTEN, gain-of-function mutations in AKT and PDK1, or upregulation of receptor tyrosine kinases. TQB3525 is an orally bioavailable, potent, dual catalytic site inhibitor of PI3Ka and PI3Kd. Tumor growth inhibition has been demonstrated in multiple xenograft osteosarcoma models with PI3K-mutant, PTEN-null cell lines. The investigators try to investigate TQB3525 in primary osteosarcoma and other bone tumors for its safety, tolerability, dose-limiting toxicities (DLT), MTD and antitumor efficacy.

TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss

Phase I Study of TQB3525, Phosphatidylinositol-3-Kinase α and δ Inhibitors, in Patients With Advanced Bone Sarcomas

from starting treatment to progression/death

Peking University People's Hospital

Director, Head of Msculoskeletal Tumor Center

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

RH324

Charles Packard

Afshin Dowlati, MD

Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer

This is a Phase 1 open label dose ranging study to assess the safety and tolerability of oral RH324 in advanced non-small cell lung cancer

Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

A Phase 1 Open Label Dose Ranging Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

Percentage of Adverse Events Summarized by Causality and Grade

Percentage of Subjects with a Clinically Relevant Change from Baseline on Physical Exam and Vital Signs

Percentage of Subjects with a Clinically Relevant Change from Baseline on Blood and Urine Laboratory Values

Percentage of Subjects with a Clinically Relevant Change from Baseline on the 12-Lead Electrocardiogram

Percentage of Subjects with a Clinically Relevant Change from Baseline in Quality of Life Based on the Eastern Cooperative Oncology Group Performance Status Levels

ReHeva Biosciences,Inc.

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Fluorouracil

Cisplatin

Patients who had chemoradiotherapy before surgery.

Patients who had chemotherapy before surgery.

Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Neoadjuvant chemoradiotherapy

Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

Oesophagectomy

Neoadjuvant chemotherapy

Herui Yao, PhD

Haiyu Zhou, PhD

Michael Lanuti, PhD

To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.

Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.

Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）

Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)

The datasets used or analysed during the current study are available from the corresponding author on reasonable request.

The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up.

DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause

R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin).

pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens.

Guangdong Provincial People's Hospital

Massachusetts General Hospital

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Principal Investigator

Menopause

Herbal and Botanical

Black Cohosh

Using Remifemin during LHRH-a treatment in breast cancer

No intervention during LHRH-a treatment in breast cancer

Remifemin 0.2g po bid\*12 weeks at the beginning of the LHRH-a treatment

Remifemin

Xingfei Yu

LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem.

Ovarian function suppression (OFS) or protection has been studied widely in breast cancer. As an common drug in clinic, LHRH-a is an important method for OFS in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem. Remifemin (cimicifuga racemosa / black cohosh) is effective in climacteric symptoms as a hormone replacement treatment, some research concluded that it is also safe in breast cancer patients who are postmenopausal or taking tamoxifen suffering from climacteric symptoms. While in China, more than 2/3 breast cancer patients are pre/peri-menopause, and some part of them should take OFS as an hormone treatment. OFS can cause sever climacteric symptoms in a short time. The investigators aim to estimate the effect and safety of Remifemin in climacteric symptoms caused by OFS in breast cancer.

Remifemin Preventing the Climacteric Symptoms in Breast Cancer

The Effect of Remifemin in Preventing the Climacteric Symptoms Caused by LHRH-a Treatment in Breast Cancer: a Randomized II-stage Clinic Research

Scoring according to Kupperman item scale (Total: 0-48, the score higher the symptoms are severer) which includes of hot flash, sweat, insomnia, anxious, depressed, vertigo, fatigue, arthralgia, headache, palpitate (each item has a weighting coefficient according to four grade scores: no symptom \*0, sometimes \*1, always \*2, influent life \*3).

Zhejiang Cancer Hospital

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

This study is a follow-up study without intervention.

Observation without intervention

This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.

BS-FU01 is a follow-up study for patients treated with FluBHPVE6E7 in previous phase 1 and 2 interventional studies. The aim of the follow-up study is to assess the safety and immunogenicity of FluBHPVE6E7, changes in the HPV infection status, cervical cytology, and biodistribution after treatment with FluBHPVE6E7 in previous studies.

Blood samples for determination of the immune response Nasal secretion and blood samples for biodistribution Cervical smear for cytology and HPV test Urine for Pregnancy test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer	NCT03577743	Metastatic Trip... Safety Issues Efficacy	Bevacizumab	18 Years - 75 Years	Assiut University
Treatment of MB07133 Plus Sintilimab in Patients With Hepatocellular Carcinoma	NCT06141109	Safety Issues Efficacy MTD	Sintilimab 200m...	18 Years - 70 Years	Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Motorized Spiral Colonoscopy Trial: A First Feasibility Trial	NCT03000361	Colonoscopy Safety Issues Adenoma	Motorized Spira...	18 Years -	Evangelisches Krankenhaus Düsseldorf
IPG7236 in Patients With Advanced Solid Tumors	NCT05142592	Safety Issues Tolerability Pharmacokinetic...	IPG7236	18 Years -	Nanjing Immunophage Biotech Co., Ltd
TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss	NCT04690725	Safety Issues Efficacy, Self	TQB3525	12 Years -	Peking University People's Hospital
Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer	NCT05580172	Safety Issues	RH324	18 Years -	ReHeva Biosciences,Inc.
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）	NCT04027543	Radiotherapy Si... Chemotherapy Ef... Oesophageal Car... Effect of Drugs Safety Issues	Neoadjuvant che... Oesophagectomy Neoadjuvant che...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Effect of Bevacizumab in Metastatic Triple Negative Breast Cancer	NCT03577743	Metastatic Trip... Safety Issues Efficacy	Bevacizumab	18 Years - 75 Years	Assiut University
TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss	NCT04690725	Safety Issues Efficacy, Self	TQB3525	12 Years -	Peking University People's Hospital
Remifemin Preventing the Climacteric Symptoms in Breast Cancer	NCT03339882	Effect of Drugs Safety Issues	Remifemin	18 Years - 55 Years	Zhejiang Cancer Hospital
IPG7236 in Patients With Advanced Solid Tumors	NCT05142592	Safety Issues Tolerability Pharmacokinetic...	IPG7236	18 Years -	Nanjing Immunophage Biotech Co., Ltd
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）	NCT04027543	Radiotherapy Si... Chemotherapy Ef... Oesophageal Car... Effect of Drugs Safety Issues	Neoadjuvant che... Oesophagectomy Neoadjuvant che...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects	NCT04528407	Safety Issues HPV Infection	Observation wit...	-	BlueSky Immunotherapies GmbH

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